NCT06171841

Brief Summary

One approach to significantly reducing resistance training intensity while maintaining effectiveness in muscle mass and strength development involves conducting training sessions under hypoxic conditions. This is likely due to heightened physiological responses. While sports science research indicates a substantial impact of hypoxic conditions on immediate increases in metabolic stress and augmented hormonal responses, recent findings suggest that the role of their influence on skeletal muscle adaptations post-resistance training under hypoxic conditions remains unknown. Additionally, there is a lack of reports on whether the type of hypoxia applied via blood flow restriction or chamber differentiates the increase in secretion of these catecholamines in both immediate and long-term aspects.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 15, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2024

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

November 25, 2023

Last Update Submit

June 10, 2024

Conditions

Outcome Measures

Primary Outcomes (8)

  • Force Output

    Force plate will be used to quantify maximum absolute (N) and relative force output (body mass divided per force output in N/kg) during maximum voluntary isometric back squat in a 100ms time frame. Participants will be pushing as hard and as fast as they can on an unmoveable barbell while standing on a force plate.

    Immediately pre and post first and last training session

  • One-Repetition Maximum

    One-Repetition Maximum test in leg press exercise will be performed to quantify maximum lower body dynamic strength (kg). Participants will be performing single repetitions of leg press exercise with increasing load until volitional failure.

    within 5 days from the start and end of training

  • Maximum Number of Repetitions

    A maximum number of repetitions in leg press exercise will be performed to quantify lower body strength endurance (number). Participants will be performing leg press exercise at 50% of one-repetition maximum until volitional failure.

    within 5 days from the start and end of training

  • Countermovement Jump Height

    Countermovement jump height will be performed estimated via take-off velocity performed on force plates to Participants will perform 3 trials on force plate.

    Immediately pre and post first and last training session

  • Countermovement Jump Power Output

    Countermovement jump performance will be performed to quantify maximum lower body relative and absolute power-output (W/kg and W), and jump height (cm) with concomitant assessment of contraction depth (cm) and contraction time (ms). Participants will perform 3 trials on force plate.

    Immediately pre and post first and last training session

  • Catecholamine Response

    A blood sample will be analyzed to quantify changes in epinephrine and norepinephrine level changes.

    Immediately pre and post first and last training session

  • Muscle Stiffness

    Myotonometry measure will be used to quantify changes in vastus medialis oblique muscle stiffness in N/m

    Immediately pre and post first and last training session

  • Muscle Thickness

    Ultrasonography measure will be used to quantify changes in vastus medialis oblique cross-sectional area.

    within 5 days from the start and end of training

Secondary Outcomes (3)

  • Perception of Pain

    Immediately pre and post every training session

  • Perception of Effort

    Immediately pre and post every training session

  • Blood Pressure

    Immediately pre and post first and last training session

Other Outcomes (4)

  • Total Body Mass

    within 5 days from the start and end of training

  • Percentage Body Fat

    within 5 days from the start and end of training

  • Bone Mass Density

    within 5 days from the start and end of training

  • +1 more other outcomes

Study Arms (5)

Low-Intensity Normoxia

ACTIVE COMPARATOR

Participants will be breathing room air, and perform low-intensity lower-body resistance exercise.

Other: low-intensity resistance training

High-Intensity Normoxia

ACTIVE COMPARATOR

Participants will be breathing room air, and perform high-intensity lower-body resistance exercise.

Other: high-intensity resistance training

Low-Intensity Normoxia with Blood Flow Restriction

EXPERIMENTAL

Participants will be breathing room air, and perform low-intensity lower-body resistance exercise combined with blood flow restriction.

Other: low-intensity resistance training combined with blood flow restriction

Low-Intensity Hypoxia

EXPERIMENTAL

Participants will be breathing a 13% oxygen gas mixture, and perform low-intensity lower-body resistance exercise.

Other: low-intensity resistance training in hypoxia condition

Low-Intensity Hypoxia with Blood Flow Restriction

EXPERIMENTAL

Participants will be breathing a 13% oxygen gas mixture, and perform low-intensity lower-body resistance exercise combined with blood flow restriction.

Other: low-intensity resistance training combined with blood flow restriction in hypoxia condition

Interventions

4 sets of 30/15/15/15 repetitions of leg press exercise with a load of 20-30% of one-repetition maximum (weeks 1-3: 20%, weeks 4-6: 30%) in normoxic conditions performed twice a week for 6 weeks.

Low-Intensity Normoxia

4 sets of 10 repetitions of leg press exercise at 70-80% one-repetition maximum (weeks 1-3: 70%, weeks 4-6: 80%) in normoxic conditions performed twice a week for 6 weeks.

High-Intensity Normoxia

4 sets of 30/15/15/15 repetitions of leg press exercise with a load of 20-30% of one-repetition maximum (weeks 1-3: 20%, weeks 4-6: 30%) in normoxic conditions with lower-limbs blood flow restriction (80% total occlusion pressure) performed twice a week for 6 weeks.

Low-Intensity Normoxia with Blood Flow Restriction

4 sets of 30/15/15/15 repetitions of leg press exercise with a load of 20-30% of one-repetition maximum (weeks 1-3: 20%, weeks 4-6: 30%) in hypoxia conditions (3500 meters above sea) performed twice a week for 6 weeks.

Low-Intensity Hypoxia

4 sets of 30/15/15/15 repetitions of leg press exercise with a load of 20-30% of one-repetition maximum (weeks 1-3: 20%, weeks 4-6: 30%) in normobaric hypoxia conditions (3500 meters above sea) with lower-limbs blood flow restriction (80% total occlusion pressure) performed twice a week for 6 weeks.

Low-Intensity Hypoxia with Blood Flow Restriction

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Regularly physically active (at least 30 mins of structured exercise 3 times per week),
  • Sea-level natives,
  • Experienced in resistance training (at least one year of experience in regular resistance exercise)

You may not qualify if:

  • presence of any medical risk factors to exercise and/or exposure to altitude
  • presence of any medical condition that would make the protocol unreasonably hazardous for the participant
  • smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Jerzy Kukuczka Academy of Physical Education

Katowice, Silesian Voivodeship, 40-065, Poland

Location

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 25, 2023

First Posted

December 15, 2023

Study Start

November 20, 2023

Primary Completion

June 20, 2024

Study Completion

July 1, 2024

Last Updated

June 11, 2024

Record last verified: 2024-06

Locations